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Busol - 0.004 mg/ml Solution for Injection for Cattle, Horses, Rabbits

Information leaflet

                 Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!
                                                                Revised 29/03/2010 – AN 00509/2009

1.   NAME OF THE VETERINARY MEDICINAL PRODUCT
Buserelin aniMedica 0,004 mg/ml – Injektionslösung für Rinder, Pferde, Kaninchen      (Germany)
Buserelin aniMedica 0.004 mg/ml – Injektionslösung für Rinder, Pferde, Kaninchen      (Austria)
Buserelin aniMedica 0,004 mg/ml roztwór do wstrzykiwan dla bydla, koni i królików     (Poland)
Busol – 0.004 mg/ml solution injectable pour bovines, equines, lapins                 (France)
Busol – 0.004 mg/ml solution for injection for cattle, horses, rabbits  (United Kingdom)

2.    QUALITATIVE AND QUAN TITATIVE COMPOSITION
Each ml of solution for injection contains:

Active substance:
Buserelin acetate                       0.0042 mg
(equivalent to Buserelin                0.004 mg)

Excipient(s):
Benzyl alcohol                          20.0 mg

For a full list of excipients, see section 6.1.

3.    PHARMACEUTICAL FORM
Solution for injection
Clear, colourless liquid.

4.    CLINICAL PARTICULARS

4.1 Target species
Cattle, horse, rabbit

4.2 Indications for use specifying the target species
In cattle:
- Early cycle induction post partum
- Treatment of follicular cysts
- Improvement of conception rate in artificial insemination procedures, also after synchronisation of
oestrus with a PGF2a analogue. Results may however vary depending on breeding conditions.

In horses :
- Induction of ovulation to synchronise ovulation more closely with mating
- Improvement of conception rate

In rabbits:
- Improvement of conception rate
- Induction of ovulation in post partum insemination.

4.3 Contraindications
None.

4.4 Special warnings for each target species
Treatment with a GnRH analogue is only symptomatic; the causes underlying a fertility disorder are
not eliminated by this treatment.




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              Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!
                                                             Revised 29/03/2010 – AN 00509/2009
4.5   Special precautions for use
Special precautions for use in animals
Observe aseptic precautions.
Special precautions to be taken by the person administering the veterinary medicinal
       product to animals
Avoid eye and skin contact with the solution for injection. In case of accidental eye contact, rinse
thoroughly with water. Should skin contact with the product occur, wash the exposed area
immediately with soap and water, as GnRH analogues may be absorbed through the skin.
Pregnant women should not administer the product, as buserelin has been shown to be foetotoxic
in laboratory animals. When administering the product, care should be taken to avoid accidental
self-injection by ensuring that animals are suitably restrained and the application needle is shielded
until the moment of injection. Women of child-bearing age should administer the product with
caution. In case of accidental self-injection, seek medical advice immediately and show the
package insert or the label to the physician.

4.6 Adverse reactions (frequency and seriousness)
None known.

4.7 Use during pregnancy, lactation or lay
The product is intended for use to improve pregnancy rate, induce ovulation etc. and should
therefore be used prior to mating or insemination and not during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction
No data available.

4.9 Amounts to be administered and administration route
The dose per animal is 10 to 20 µg buserelin in cows, 20 to 40 µg buserelin in mares and 0.8 µg
buserelin in rabbits.

      Species / Indication                         ml Buserelin aniMedica          µg Buserelin
      Cattle
      Fertility disorders of ovarian origin, in
      particular:
      Follicular cysts with or without symptoms                             5 ml          20 µg
      of nymphomania
      Early cycle induction post partum                                    5 ml           20 µg
      Improvement of conception rate in                                  2.5 ml           10 µg
      artificial insemination procedures, also
      after synchronisation of oestrus with a
      PGF2a analogue.
      (Results may however vary depending
      on breeding conditions)
      Mares
      Induction of ovulation to synchronise                              10 ml            40 µg
      ovulation more closely with mating.
      (If ovulation has not occurred within 24
      hours after treatment, then the injection
      should be repeated.)
      Improvement of conception rate                                     10 ml            40 µg
      Rabbits
      Improvement of conception rate                                     0.2 ml           0.8 µg


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